Scient'X Tribeca VBR

FDA 510(k) K080588 · Scient'X USA, Inc.

Substantially Equivalent

510(k) numberK080588

Submission

Device name
Scient'X Tribeca VBR
Applicant
Scient'X USA, Inc.
Maitland, FL, US
Received
March 3, 2008
Decision date
May 30, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Specialty
Orthopedic
Implant
Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

510(k)DeviceApplicantDecision
K261049Scala® TLMAX · Traditional Spineart SA08/20/2026SE
K261430TruLift Expandable SystemMAX · Traditional Life Spine, Inc.07/28/2026SE
K253011Catalyft PL Expandable Interbody SystemMAX · Traditional Medtronic Sofamor Danek USA, Inc.07/17/2026SE
K261020Symmetrix™ L Spinal SystemMAX · Traditional Medtronic Sofamor Danek USA, Inc.07/14/2026SE
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional SeaSpine Orthopedics Corporation07/01/2026SE
K253151Fule Interbody Fusion Cage SystemMAX · Traditional Beijing Fule Science & Technology Development…06/15/2026SE
K261159Exceed® Biplanar Expandable Interbody SystemMAX · Traditional Spine Wave, Inc.05/29/2026SE
K253894BMD Titanium Spinal Fusion SystemMAX · Traditional Global Biomedica s.r.o.05/28/2026SE
K260506Ventana® P/T Lumbar Interbody SystemMAX · Traditional Spinal Elements, Inc.05/15/2026SE
K260837VersaLift Expandable SystemMAX · Traditional Life Spine, Inc.05/12/2026SE

More from Life Spine, Inc.

510(k)DeviceDecision
K081548Anterior Buttress PlateKWQ · Traditional 01/29/2009SE
K053292Davantis/Antelys Vertebral Body ReplacementsMQP · Special 01/19/2006SE
K031290Modification to Easys Transverse ConnectionMNH · Special 05/13/2003SE

Questions and answers

When was Scient'X Tribeca VBR cleared by the FDA?

Scient'X Tribeca VBR (K080588) received a 510(k) decision of Substantially Equivalent on May 30, 2008, 88 days after the submission was received.

What is the product code of K080588?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.